This study will investigate how well OC-01 (varenicline) nasal spray can treat the signs and symptoms of dry eye disease in those Sjogren's Syndrome. Patients at least 18 years old with moderate-to-severe Sjogren's dry eye disease may be eligible for this study. If you are eligible to participate in the study and you decide to join, there will be 3 study visits over approximately 1 month. You will also self-administer the nasal spray at home every day, 2 times a day during this month.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
39
OC-01 (varenicline solution) 0.03 mg nasal spray
Scheie Eye Institute at the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Mean Change in Cornea Staining
The National Eye Institute (NEI) scale is the method that will be used to measure corneal staining using fluorescein strips on a scale of 0-3. The scale is a density-based scoring from 0-3 with 0 indicating no staining and 3 indicating highest density of staining.
Time frame: Baseline to Day 28
Mean Change in Eye Dryness Score as Measured by the Visual Analogue Scale (VAS)
VAS is a validated, subjective measure for acute and chronic pain. Patients rate eye dryness on a scale of 0-100 where 0 corresponds to "no discomfort" and 100 corresponds to "maximal discomfort."
Time frame: Baseline to Day 28
Mean Change in Conjunctival Staining
The Van Bijsterveld and Utrecht scale is the method that will be used to measure conjunctival staining while using lissamine green dye. The scale is a from 0-3 with 0 indicating no staining and 3 indicating confluent staining.
Time frame: Baseline to Day 28
Mean Change in Best Corrected Visual Acuity
LogMAR or Logarithm of the Minimum Angle of Resolution was the method used for measuring best correct visual acuity (BCVA). LogMAR is a scale from -0.2 to 1.6 where the letter size is described in LogMAR units such that LogMAR -0.2 is equivalent to 20/12 (best vision) and LogMAR 1.6 is equivalent to 20/800 (Worse vision). The letter size change in units of 0.1 LogMAR from one row to the next.
Time frame: Baseline to Day 28
Mean Change in Dry Mouth Scale
VAS is a validated, subjective measure for acute and chronic pain. Patients rate mouth dryness on a scale of 0-100 where 0 corresponds to "no discomfort" and 100 corresponds to "maximal discomfort."
Time frame: Baseline to Day 28
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Mean Change in Nose Dryness Scale
VAS is a validated, subjective measure for acute and chronic pain. Patients rate nose dryness on a scale of 0-100 where 0 corresponds to "no discomfort" and 100 corresponds to "maximal discomfort."
Time frame: Baseline to Day 28